510(k) Report

510(k) · Cleared

Cleared

Probe Personal Lubricant - Classic

K952464510(k) TraditionalCleared Nov 22, 1995180-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Davryan Laboratories, Inc. · HIS Condom

Cleared on Nov 22, 1995 after a 180-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 22, 1995
Review
180 days
Class
Class II
Product code
HIS
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952464 Probe Personal Lubricant - ClassicDavryan Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK080042 Spirus Medical Surgical InstrumentSpirus Medical, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080042Spirus Medical Surgical InstrumentSpirus Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952464Probe Personal Lubricant - ClassicDavryan Laboratories, Inc.1995—
+1K080042Spirus Medical Surgical InstrumentSpirus Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K952464, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HIS device

  1. #1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080042Spirus Medical Surgical InstrumentSpirus Medical, Inc.20080

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080042 (Spirus Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIS

5in 2025

2007: 72008: 32009: 52010: 12011: 32012: 72013: 42014: 72015: 32016: 52017: 42018: 22019: 12020: 42021: 52022: 102023: 22025: 52026 (partial year): 2
2007high 10 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIS

99in 2025

2007: 128 days median2008: 157 days median2009: 241 days median2011: 54 days median2012: 106 days median2013: 208 days median2014: 242 days median2015: 136 days median2016: 115 days median2017: 102 days median2020: 240 days median2021: 233 days median2022: 112 days median2025: 99 days median
2007high 242 (2014) · low 54 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIS

1in 2013

2007: 12012: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HIS

20in 2025

2007: 102008: 112009: 122010: 222011: 152012: 102013: 192014: 162015: 82016: 52017: 82018: 112019: 152020: 122021: 162022: 182023: 102024: 72025: 20
2007high 22 (2010) · low 5 (2016)2025

MAUDE reports naming product code HIS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077128110
20083157011
20095241012
20101—022
2011354015
20127106110
20134208119
20147242016
2015313608
2016511505
2017410208
20182—011
20191—015
20204240012
20215233016
202210112018
20232—010
20240—07
2025599020
20262—0—

More from Davryan Laboratories, Inc.

2 FDA decisions under this applicant name. See the company

  • K952465Probe Personal Lubricant - Silky LightDavryan Laboratories, Inc. · 1995

Recent decisions in HIS

The HIS category page

  • K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant…Shanghai Personage Hygiene Products Co., Ltd. · 2026
  • K252622Male Latex Condom HAOkamoto USA, Inc. · 2026
  • K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex Limited · 2025
  • K250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd. · 2025
  • K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc. · 2025

https://510kreport.com/device/K952464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952464: Probe Personal Lubricant - Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952464

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026